高效液相色谱法测定盐酸氨溴索口服溶液中杂质B的含量

目的建立HPLC法测定盐酸氨溴索口服溶液中杂质B[反式-4-(6,8-二溴-四氢喹唑啉环己醇)盐酸盐]的含量。方法用Agilent TC-C18色谱柱,以乙腈-0.01 mol·L-1磷酸氢二铵(50:50)为流动相,UV检测波长为248 nm,室温下测定盐酸氨溴索口服溶液中杂质B的含量。结果杂质B在1.242 5⁴9.7μg·mL-1呈良好的线性关系,r=0.999 9,回收率为99.4%,RSD为0.86%(n=3)。结论该方法专属性,简单可行,为更好的控制盐酸氨溴索口服溶液质量提供参考。

HPLC determination of the content of impurity B in Ambroxol hydrochloride oral solution

Objective To establish an HPLC method to determine the content of impurity B [trans-4-（6,8-dibromo-1, 4-dihydroquinazolin-3（2H）-yl） cyclohexanol hydrochloride] in Ambroxol hydrochlorid oral solution. Methods The analysis was performed on a Agilent TC-C18 column at room temperature, the mobile phase was consisted of acetonitrile-0.01 mol·L-1 ammonium hydrogen phosphate（50 ：50）, the detection wavelength was 248 nm. Results The standard curve was linear at 1.242 5- 49.7 μg·mL^- 1, r = 0.999 9, the average recovery was 99.4%, and RSD was 0.86%（n = 3）. Conclusion The method is specifi c, simple and feasible, which provids reference for the quality control of Ambroxol hydrochloride oral solution.